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510(k) Data Aggregation

    K Number
    K040052
    Device Name
    FINE SURGICAL CIRCUMCISION CLAMP
    Manufacturer
    FINE SURGICAL INSTRUMENT CORP.
    Date Cleared
    2004-04-09

    (88 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    FINE SURGICAL INSTRUMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Circumcision Clamp is an instrument used in a procedure to compress the foreskin of the penis during circumcision of male infant or child.
    Device Description
    The Fine Surgical Gomco Circumcision Clamp is a disposable medical device that is constructed of chrome plated brass. The device will be sold non sterile for further processing (ie. Packaging and sterilization) by the final distributor. We do not intend to sell these devices directly to the end user.
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